• The Journal of the Convergence on Culture Technology
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• v.8 no.5
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• pp.1-7
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• 2022

Korean medical device industry has laid the foundation for full-fledged growth and development with the G7 medical engineering technology development project that started in 1995, and the medical device production in 2020 increased by 8.52 times and the export by 13.94 times, compared to those in 2001. In early years, electronic medical devices such as ultrasound imaging device contributed greatly to Korean medical industry, but top ranks in medical device production and export in Korea has shifted recently to in vitro diagnostic medical devices and dental implants. However, the share of imported medical devices in the Korean medical device market have not changed much; it still ranges in 60 to 70%, as the Korean medical device industry produces and exports mid- to low-priced medical devices, and technology-intensive and capital-intensive high-priced medical devices are mainly imported. In this paper, we compare the leading medical devices produced by major Korean companies and those by global top medical device companies to suggest strategies for the Korean medical device companies to enter the global market.

• Health Policy and Management
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• v.33 no.2
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• pp.173-184
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• 2023

Background: The coronavirus disease 2019 pandemic has been challenging the healthcare service, i.e., the vitalization of the point of care accompanying self-testing in vitro diagnostic medical devices (IVDs). This study aims to suggest priority criteria to classify self-testing IVDs using the analytic hierarchy process technique. Methods: Two dimensions of the characteristics embedded in the IVDs and the diseases to be diagnosed with self-testing IVDs were parallelly considered and independently investigated. In addition, three expert panels consisting of laboratory medical doctors (n=11), clinicians (n=10), and citizens (n=11) who have an interest in the selection of self-testing IVDs were asked to answer to questionnaires. Priorities were derived and compared among each expert panel. Results: First of all, ease of specimen collection (0.241), urgency of the situation (0.224), and simplicity of device operation (0.214) were found to be the most important criteria in light of the functional characteristics of self-testing IVDs. Medical doctors valued the ease of specimen collection, but the citizen's panel valued self-management of the disease more. Second, considering the characteristics of the diseases, the priority criteria were shown in the order of prevalence of diseases (0.421), fatality of disease (0.378), and disease with stigma (0.201). Third, medical doctors responded that self-testing IVDs were more than twice as suitable for non-communicable diseases as compared to communicable diseases (0.688 vs. 0.312), but the citizen's group responded that self-testing IVDs were slightly more suitable for infectious diseases (0.511 vs. 0.489). Conclusion: Our findings suggested that self-testing IVDs could be primarily classified as the items for diagnosis of non-communicable diseases for the purpose of self-management with easy specimen collection and simple operation of devices, taking into account the urgency of the situation as well as prevalence and fatality of the disease.

• Korean Journal of Veterinary Research
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• v.55 no.2
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• pp.97-103
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• 2015

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

• Journal of the Korean institute of surface engineering
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• v.55 no.6
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• pp.390-397
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• 2022

Parylene-C which was mainly used for industries such as electronics, machinery and semiconductors has recently been in the spotlight in the medical field due to its properties such as corrosion resistance and biocompatibility. In this study we intend to derive a plan to improve the bonding strength of Parylene-C coating with the SUS304 base material for medical use which can be applied to various medical fields such as needles, micro needles and in vitro diagnostic device sensors. Through plasma pretreatment the bonding strength between Parylene-C and metal materials was improved. It was confirmed that the coated surface was hydrophobic by measuring the contact angle and the improvement of the surface roughness of the sample manufactured through CNC machining was confirmed by measuring the surface roughness with SEM. Through the above results, it is thought that it will be effective in increasing usability and reducing pain in patients by minimizing friction when inserting medical devices and in contact with skin. In addition it can be applied to various application fields such as human implantable stents and catheters, and is expected to improve the performance and lifespan of medical parts.

• KIPS Transactions on Computer and Communication Systems
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• v.12 no.2
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• pp.77-84
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• 2023

Dengue virus transmission is a viral infection disease between humans and Aedes mosquitoes. Dengue is ubiquitous throughout the tropics and subtropical zones, where 1/3 of the global population live. The weather in Korea is also changing to subtropical weather, resulting in increased vulnerable Korean population to dengue virus transmission. It is important to control and prevent the dengue risk with track-recording & monitoring system. It is also required to have the control system to treat and monitor dengue patients with various cases such as regions, ages, genders according to the track-record of the disease. In this paper, we developed a Dengue Control & Prevention System, which can monitor and control dengue outbreaks in real-time with in-vitro diagnostic devices. Dengue Control & Prevention System is composed of in-vitro diagnostic device, which is a fluorescent immunoassay, and real-time monitoring system. In the future, we expect that our Dengue Control & Prevention System can be upgraded to have various disease information from Korea Disease Control and Prevention Agency for government policies and diseases control in Korea.

• Journal of Biomedical Engineering Research
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• v.43 no.4
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• pp.199-213
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• 2022

EN ISO 14971:2012 a risk management standard approved and applied as a European standard in 2012, will be adopted and applied as ISO 14971:2019 published in December 2019, ISO/TR 24971(Guidance) published in June 2020 from May 2022. After that, it is applied to IVDD surveillance and IVDR new and conversion, and the manufacturer is already preparing for application or is starting preparation for application. In addition, 98/78/EEC IVDD applied from 1998 will also be applied as REGULATION (EU) 2017/746 IVDR from May 2022. In particular, in IVDR, the requirements for post-marketing investigations such as Post Market Surveillance (PMS), Summary of safety and performance(SSP), Periodic Safety Update Report(PSUR) and Post Market Performance Follow Up(PMPF), which were not required in the existing IVDD, increased, and the contents were also specified. This study focused on ISO14971:2019 among these strengthened and newly applied regulations, and tried to present a detailed analysis and application plan of Post Market Surveillance (PMS) required by 2017/746 IVDR.

• Korean Journal of Veterinary Research
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• v.57 no.2
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• pp.71-78
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• 2017

Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.

• Progress in Medical Physics
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• v.9 no.2
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• pp.115-121
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• 1998

In this paper, basic study of diagnostic device development for early detection of cancer, we present the optical property measurements of 12 histologically classified biological tissue and blood specimens in order to determine whether significant optical contrast exists for detection of disease(cancer). In vitro, optical properties of each 630nm, 660nm, 780n, 880nm and 940nm shows consistent changes in effective absorbtion coefficients, ${\mu}$$\_$${\alpha}$/ with tissue classification of pig an chicken and human blood according to the 27.3%, 35.4%, 45.6% and 59.1% of HCT. We found differences in optical properties at each of specific wavelengths and histologically classified biological tissue.

• Women's Health Nursing
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• v.26 no.4
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• pp.300-317
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• 2020

Purpose: Hysteroscopy can be used both to diagnose and to treat intrauterine pathologies. It is well known that hysteroscopy helps to improve reproductive outcomes by treating intrauterine pathologies. However, it is uncertain whether hysteroscopy is helpful in the absence of intrauterine pathologies. This study aimed to confirm whether hysteroscopy improves the reproductive outcomes of infertile women without intrauterine pathologies. Methods: We conducted a systematic review of 11 studies retrieved from Ovid-MEDLINE, Ovid-Embase, and the Cochrane Library. Two independent investigators extracted the data and used risk-of-bias tools (RoB 2.0 and ROBINS-I) to assess their quality. Results: Diagnostic hysteroscopy prior to in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) was associated with a higher clinical pregnancy rate (CPR) and live birth rate (LBR) than non-hysteroscopy in patients with recurrent implantation failure (RIF) (odds ratio, 1.79 and 1.46; 95% confidence interval, 1.40-2.30 and 1.08-1.97 for CPR and LBR, respectively) while hysteroscopy prior to first IVF was ineffective. The overall meta-analysis of LBR showed statistically significant findings for RIF, but a subgroup analysis showed effects only in prospective cohorts (odds ratio, 1.40 and 1.47; 95% confidence interval, 0.62-3.16 and 1.04-2.07 for randomized controlled trials and prospective cohorts, respectively). Therefore, the LBR should be interpreted carefully and further research is needed. Conclusion: Although further research is warranted, hysteroscopy may be considered as a diagnostic and treatment option for infertile women who have experienced RIF regardless of intrauterine pathologies. This finding enables nurses to educate and support infertile women with RIF prior to IVF/ICSI.

• Imaging Science in Dentistry
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• v.43 no.3
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• pp.171-177
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• 2013

Purpose: The purpose of this study was to compare the efficacy of two imaging modes in a cone beam computed tomography (CBCT) system in detecting root fracture in endodontically-treated teeth with fiber posts or screw posts by selecting two fields of view. Materials and Methods: In this study, 78 endodontically-treated single canal premolars were included. A post space was created in all of them. Then the teeth were randomly set in one of 6 artificial dental arches. In 39 of the 78 teeth set in the 6 dental arches, a root fracture was intentionally created. Next, a fiber post and a screw post were cemented into 26 teeth having equal the root fractures. High resolution (HiRes) and standard zoom images were provided by a CBCT device. Upon considering the reconstructed images, two observers in agreement with each other confirmed the presence or absence of root fracture. A McNemar test was used for comparing the results of the two modes. Results: The frequency of making a correct diagnosis using the HiRes zoom imaging mode was 71.8% and in standard zoom was 59%. The overall sensitivity and specificity in diagnosing root fracture in the HiRes mode were 71.79% and 46.15% and in the standard zoom modes were 58.97% and 33.33%, respectively. Conclusion: There were no significant differences between the diagnostic values of the two imaging modes used in the diagnosis of root fracture or in the presence of root canal restorations. In both modes, the most true-positive results were reported in the post space group.